SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 72204409 |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The device was fractured approximately 1/3 of the way down from the distal end.There was biological debris on the returned item.An assessment of material characteristics found that based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A risk management review found that the reported failures and/or harm were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that during an acl procedure, the threads of the screw biosure regenesorb were bending when they got in contact with tissue.The screw was removed.An instrument of 8mm was used to prepare the site before insertion attempt.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.As per investigation results, it was found the device is fractured approximately 1/3 of the way down from the distal end.
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Search Alerts/Recalls
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